By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by UnitedHealthcare in Texas: Complete Coding and Appeals Guide

Answer Box: To get Givlaari (givosiran) covered by UnitedHealthcare in Texas, you need prior authorization with specific documentation: confirmed acute hepatic porphyria diagnosis (ICD-10 E80.21), elevated ALA/PBG lab results, at least 2 documented attacks in 6 months, and evidence of hemin failure/intolerance. Submit via the UnitedHealthcare Provider Portal using HCPCS code J0223. If denied, you have 180 days to appeal internally, then can request external review through Texas Department of Insurance within 4 months. Start by gathering attack documentation and lab results today.

Table of Contents

Coding Basics: Medical vs Pharmacy Benefit

Givlaari (givosiran) is exclusively covered under UnitedHealthcare's medical benefit, not pharmacy benefit. This matters because:

  • Medical benefit: Uses HCPCS codes, requires provider administration, billed on UB-04 forms
  • Pharmacy benefit: Would use NDC numbers, patient picks up at pharmacy (not applicable for Givlaari)

UnitedHealthcare processes Givlaari claims through their medical policy using HCPCS code J0223. The drug must be administered by a healthcare provider monthly via subcutaneous injection.

Coverage Pathway Overview

Step Requirement Timeline Responsibility
1. Prior Authorization Submit PA with clinical documentation 15 business days standard, 72 hours expedited Provider
2. Diagnosis Verification Confirm AHP with ICD-10 E80.21 Immediate Provider
3. Lab Documentation Provide elevated ALA/PBG results Within past 12 months Provider
4. Step Therapy Document hemin failure/intolerance Before Givlaari approval Provider

ICD-10 Mapping for Acute Hepatic Porphyria

The correct ICD-10 coding is crucial for UnitedHealthcare approval. Use these specific codes:

Primary Diagnosis Codes

E80.21 - Acute intermittent (hepatic) porphyria

  • Most common AHP subtype
  • Use when diagnosis is confirmed as AIP
  • Required for Givlaari coverage

E80.20 - Unspecified porphyria

  • When AHP is confirmed but subtype unclear
  • Acceptable for coverage decisions

E80.29 - Other porphyria

  • For variegate porphyria (VP), hereditary coproporphyria (HCP)
  • Less common but covered subtypes

Documentation Requirements

Your medical records must include:

  • Biochemical evidence: Elevated urinary porphobilinogen (PBG) >3x upper limit of normal
  • Clinical symptoms: Documented acute neurovisceral attacks (abdominal pain, neurological symptoms)
  • Attack frequency: At least 2 documented attacks requiring medical intervention in past 6 months
  • Genetic testing: If available, include mutation analysis results
Clinician Corner: The medical necessity letter should explicitly state: "Patient has confirmed acute hepatic porphyria (E80.21) with biochemically documented attacks (elevated PBG levels of [specific value] on [date]) and inadequate response to hemin therapy, requiring chronic prophylaxis with givosiran per FDA indication."

Product Coding: HCPCS, NDC, and Units

Essential Billing Codes

HCPCS Code: J0223 (Injection, givosiran, 0.5 mg) NDC: 71336-1001-01 (11-digit format required) Administration Code: CPT 96372 (subcutaneous injection)

Units Calculation

Givlaari dosing is 2.5 mg/kg monthly based on actual body weight:

Formula: Patient weight (kg) × 2.5 mg/kg ÷ 0.5 mg = billing units

Examples:

  • 60 kg patient: 60 × 2.5 = 150 mg ÷ 0.5 = 300 units
  • 80 kg patient: 80 × 2.5 = 200 mg ÷ 0.5 = 400 units

Maximum: 756 units per month (equivalent to 378 mg or approximately 2 vials)

Modifier Usage

  • JW modifier: When drug is discarded (waste)
  • JZ modifier: When no drug is discarded
  • Use appropriate modifier based on actual administration

Clean Prior Authorization Request

UnitedHealthcare requires comprehensive documentation for Givlaari approval. Here's what makes a clean request:

Required Elements Checklist

✓ Patient Demographics

  • Full name, DOB, member ID
  • UnitedHealthcare plan details
  • Prescribing physician information

✓ Diagnosis Documentation

  • ICD-10 code E80.21 (or appropriate variant)
  • Date of diagnosis
  • Confirming specialist (hematologist, hepatologist, gastroenterologist)

✓ Laboratory Evidence

  • Elevated ALA/PBG levels with dates
  • Reference ranges and actual values
  • Genetic testing results (if available)

✓ Clinical History

  • Detailed attack documentation (dates, symptoms, interventions)
  • Hospital admissions or emergency visits
  • Impact on daily functioning

✓ Step Therapy Documentation

  • Hemin (Panhematin) trial history
  • Dates of administration
  • Response or reasons for discontinuation
  • Contraindications or intolerance details

Sample Medical Necessity Statement

"This 45-year-old patient has genetically confirmed acute intermittent porphyria (AIP, E80.21) with recurrent attacks documented by elevated urinary PBG levels (15.2 mg/24h, normal <1.5). Despite hemin therapy, patient experienced 4 attacks in the past 6 months requiring hospitalization. Hemin was discontinued due to venous access complications. Givlaari is medically necessary for attack prevention per FDA indication and clinical guidelines."

Common Coding Pitfalls

Unit Conversion Errors

Wrong: Using vial count instead of mg-based units Right: Calculate based on 0.5 mg per unit (J0223 descriptor)

Mismatched Diagnosis Codes

Wrong: Using E80.0 (hereditary erythropoietic porphyria) Right: E80.21 for acute intermittent porphyria

Missing Documentation

Common gaps:

  • No recent lab values (>12 months old)
  • Insufficient attack documentation
  • Missing hemin trial details
  • Non-specialist prescriber

Benefit Channel Confusion

Wrong: Submitting through pharmacy benefit Right: Medical benefit with UB-04 form and HCPCS coding

Tip: Double-check that your billing system is set up for medical benefit claims, not pharmacy. This is the #1 reason for immediate denials.

UnitedHealthcare Verification

Before submitting your request, verify these details with UnitedHealthcare:

Pre-Submission Verification Steps

  1. Confirm Coverage: Call provider services to verify Givlaari is covered under patient's specific plan
  2. PA Requirements: Confirm current prior authorization requirements haven't changed
  3. Preferred Submission Method: Verify whether portal, fax, or mail is preferred
  4. Documentation Checklist: Confirm all required attachments are included

UnitedHealthcare Resources

Cross-Check Your Codes

Use UnitedHealthcare's coding lookup tools to verify:

  • J0223 is recognized for your patient's plan
  • NDC 71336-1001-01 matches their system
  • No recent policy updates affecting coverage

Appeals Process in Texas

If your initial prior authorization is denied, Texas law provides strong appeal rights for UnitedHealthcare members.

Internal Appeals Timeline

First Level Internal Appeal

  • Deadline: 180 days from denial notice
  • Decision timeframe: 30 days for pre-service requests
  • Expedited: 72 hours for urgent cases
  • Submit via: UnitedHealthcare Provider Portal (required for Texas Community Plan as of August 2025)

External Review Process

If internal appeals are exhausted, Texas requires UnitedHealthcare to offer Independent Review Organization (IRO) review:

Standard External Review

  • Timeline: IRO decision within 45 calendar days
  • Filing deadline: 4 months from final internal denial
  • Cost: Paid by UnitedHealthcare

Expedited External Review

  • Timeline: 72 hours for urgent medical needs
  • Concurrent filing: Can request alongside expedited internal appeal
  • Eligibility: When delay would jeopardize health

Texas-Specific Resources

  • Texas Department of Insurance: tdi.texas.gov
  • Consumer Hotline: 1-800-252-3439
  • IRO Information: 1-866-554-4926

Quick Audit Checklist

Before submitting any Givlaari request to UnitedHealthcare, review this checklist:

Pre-Submission Audit

Patient Information

  • Correct member ID and plan details
  • Patient weight documented for dosing calculation
  • All demographic information complete

Clinical Documentation

  • ICD-10 E80.21 (or appropriate code) used consistently
  • Lab values within past 12 months
  • Attack documentation with specific dates
  • Specialist involvement documented

Coding Accuracy

  • HCPCS J0223 used (not old J3490)
  • NDC 71336-1001-01 included
  • Units calculated correctly (weight × 2.5 ÷ 0.5)
  • CPT 96372 for administration

Step Therapy Compliance

  • Hemin trial documented OR
  • Clear contraindication/intolerance explanation
  • Dates and outcomes of prior therapies

Submission Method

  • Medical benefit pathway (not pharmacy)
  • Provider portal access confirmed
  • All attachments included

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements like these. Our platform analyzes denial letters and creates targeted, evidence-backed appeals that align with each payer's specific requirements, potentially saving weeks of back-and-forth communications.

FAQ

How long does UnitedHealthcare prior authorization take for Givlaari in Texas? Standard review takes up to 15 business days. Expedited review (for urgent cases) is completed within 72 hours. Submit complete documentation to avoid delays.

What if Givlaari isn't on UnitedHealthcare's formulary? Givlaari requires prior authorization but is generally covered for medically appropriate cases. Non-formulary status doesn't prevent coverage with proper documentation.

Can I request expedited review if my patient is having frequent attacks? Yes. Document that delays would jeopardize the patient's health and request expedited review. Include physician attestation of urgency.

Does step therapy always require hemin failure? UnitedHealthcare typically requires documented hemin trial unless there are clear contraindications (venous access issues, hypersensitivity) or intolerance.

What happens if the external review is denied in Texas? IRO decisions are binding on UnitedHealthcare. If approved, they must cover the treatment. If denied, you may need to explore other options or resubmit with additional evidence.

How do I calculate billing units for different patient weights? Use the formula: patient weight (kg) × 2.5 mg/kg ÷ 0.5 mg = billing units. Maximum is 756 units per month.

Who can prescribe Givlaari for UnitedHealthcare coverage? Typically requires a specialist: hematologist, hepatologist, or gastroenterologist. Primary care physicians may face additional scrutiny.

What if my patient has been stable on hemin? UnitedHealthcare generally requires evidence that hemin is inadequate (continued attacks, access issues, or complications) before approving Givlaari.

From our advocates: We've seen cases where providers submitted incomplete attack documentation—just listing "abdominal pain" without dates, severity, or interventions. The most successful appeals include detailed chronologies: "March 15, 2024: severe abdominal pain, hospitalized 3 days, hemin administered; May 2, 2024: recurrent attack despite prophylactic hemin, required IV narcotics." Specificity matters for payer review.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual circumstances and plan details. Always consult current UnitedHealthcare policies and Texas regulations for the most up-to-date requirements.

For personalized assistance with UnitedHealthcare denials and appeals, Counterforce Health provides comprehensive support to help patients access the medications they need through evidence-based appeal strategies tailored to each payer's specific requirements.

Sources & Further Reading

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